Raoul S. Concepcion, MD, FACS: Phil, one test that was being used quite a bit, that’s off the registry now, is sodium fluoride PET/CT.

Phillip Koo, MD: Correct.

Raoul S. Concepcion, MD, FACS: Where do we stand with that? I thought the NOPR registry ended for that recently, correct?

Phillip Koo, MD: You’re absolutely right. The NOPR registry has been in effect for the past 3 or 4 years. It collected data and reported that some of the data showed an increase in the change in management in those patients who received sodium fluoride PET/CT. However, the CMS did not accept that as enough evidence for approval. They did decide to extend the registry for another 2 years, and that recently closed in December of 2017. So, the registry is now closed. From what I know, there are no plans to extend that registry. In my opinion, I don’t think we’ll be seeing reimbursement from CMS for sodium fluoride PET/CT.Raoul S. Concepcion, MD, FACS: What was the strength of sodium fluoride PET/CT?

Phillip Koo, MD: There were some strengths and a lot of weaknesses. I think the strengths included the fact that it was a bone scan on steroids. It detected bony disease much better than anything we’ve done in the past. When you combined it with a CT, it helped you increase the specificity. Now you had a CT that could tell you exactly whether it was degenerative disease or something else that was causing the activity rather than a bone metastasis.

I think the limitations included the fact that overall, in the community, there were a lot of false positives. That was a concern. Despite what the literature says, in real practice, there were a lot of false positives. Another limitation was that it only imaged the bone. The newer next-generation imaging tools image bone and soft tissues better than sodium fluoride did in the past. The third limitation is the fact that sodium fluoride PET/CT imaged the bony response to disease, not the disease itself. So, this idea of flare still exists. So, for those 3 reasons it probably makes sense for us to move forward and really embrace the fluciclovines, the PSMAs, and the other tools that we have coming down the pike.

Raoul S. Concepcion, MD, FACS: But my understanding is that with fluciclovine, there’s not been a lot of work done by the company in this castration-resistant prostate cancer (CRPC) population, correct?

Phillip Koo, MD: Correct. In the CRPC space, we created RADAR for the M0 CRPC patients. This was done because there was an unmet need in that area. We’re going to talk about this for M0 CRPC, but now that there are some therapies that we could be using, what is really the value of imaging in this setting? I don’t really think we’ve established that. So, in my opinion, an imaging test needs to be safe and accurate. And then it needs to produce actionable results. If we have therapies that we could be using for these patients that provide a clinical benefit and value to our patients, why do we need imaging to change that paradigm? Again, we need to make decisions based on the available data. We have no available data that tell us that advanced imaging in this M0 CRPC population will lead to better outcomes.

Transcript Edited for Clarity

Transcript:

Raoul S. Concepcion, MD, FACS: Phil, one test that was being used quite a bit, that’s off the registry now, is sodium fluoride PET/CT.

Phillip Koo, MD: Correct.

Raoul S. Concepcion, MD, FACS: Where do we stand with that? I thought the NOPR registry ended for that recently, correct?

Phillip Koo, MD: You’re absolutely right. The NOPR registry has been in effect for the past 3 or 4 years. It collected data and reported that some of the data showed an increase in the change in management in those patients who received sodium fluoride PET/CT. However, the CMS did not accept that as enough evidence for approval. They did decide to extend the registry for another 2 years, and that recently closed in December of 2017. So, the registry is now closed. From what I know, there are no plans to extend that registry. In my opinion, I don’t think we’ll be seeing reimbursement from CMS for sodium fluoride PET/CT.Raoul S. Concepcion, MD, FACS: What was the strength of sodium fluoride PET/CT?

Phillip Koo, MD: There were some strengths and a lot of weaknesses. I think the strengths included the fact that it was a bone scan on steroids. It detected bony disease much better than anything we’ve done in the past. When you combined it with a CT, it helped you increase the specificity. Now you had a CT that could tell you exactly whether it was degenerative disease or something else that was causing the activity rather than a bone metastasis.

I think the limitations included the fact that overall, in the community, there were a lot of false positives. That was a concern. Despite what the literature says, in real practice, there were a lot of false positives. Another limitation was that it only imaged the bone. The newer next-generation imaging tools image bone and soft tissues better than sodium fluoride did in the past. The third limitation is the fact that sodium fluoride PET/CT imaged the bony response to disease, not the disease itself. So, this idea of flare still exists. So, for those 3 reasons it probably makes sense for us to move forward and really embrace the fluciclovines, the PSMAs, and the other tools that we have coming down the pike.

Raoul S. Concepcion, MD, FACS: But my understanding is that with fluciclovine, there’s not been a lot of work done by the company in this castration-resistant prostate cancer (CRPC) population, correct?

Phillip Koo, MD: Correct. In the CRPC space, we created RADAR for the M0 CRPC patients. This was done because there was an unmet need in that area. We’re going to talk about this for M0 CRPC, but now that there are some therapies that we could be using, what is really the value of imaging in this setting? I don’t really think we’ve established that. So, in my opinion, an imaging test needs to be safe and accurate. And then it needs to produce actionable results. If we have therapies that we could be using for these patients that provide a clinical benefit and value to our patients, why do we need imaging to change that paradigm? Again, we need to make decisions based on the available data. We have no available data that tell us that advanced imaging in this M0 CRPC population will lead to better outcomes.